| |   | Meghana here, welcoming you back from the holiday weekend. Don't forget to sign up for our pop-up newsletter from ASCO, "ASCO in 30 Seconds." | | | A new wave of counterfeit medicines More and more pharmacies are receiving counterfeit pills. Somewhere amid the supply chain, someone tampers with foil seals, replacing legitimate pills with fakes before shipping them to pharmacies around the country. The pills are sometimes antipsychotics, and sometimes HIV meds, according to lawsuits filed by Gilead Sciences and Johnson & Johnson. The distributors allegedly involved in the scheme have a pretty well-oiled operation, creating robust transaction histories to falsely document how the drugs are handled along the supply chain. A federal law has been in place since 2013 to attempt to curb this sort of illegal activity. But the law’s rollout has been slow and rocky, and isn’t slated to go into full effect until November 2023. Read more. | Congress doesn’t want the Aduhelm controversy repeated New bipartisan legislation from the Senate will create a “coordinating council” that will keep all FDA officials on the same page when evaluating accelerated approvals. The move is a clear response to the fracas over Alzheimer’s drug Aduhelm last year, which was approved despite a near-unanimous rejection from scientific advisers — and to the surprise of many top officials.
The proposed reforms are part of a bill that would reauthorize the fees industry pays the FDA to review products. It’s not just the Senate, however, that’s working on legislation to change the accelerated approval pathway. House lawmakers are drafting a bill that has provisions to allow the FDA to more easily rescind approvals. Read more. | Sign up for our free pop-up newsletter: ADA in 30 seconds Get insightful analysis of the data presented at the conference of the American Diabetes Association with this newsletter. STAT will be on top of all the news out of the event and will recap the most important advances in research and care for you from June 4-6. Sign up now. | Going patent-free would help prepare for pandemic Preparing for the next pandemic will require a sea change the global health framework, opines Nobel Peace Prize winner and microfinance pioneer Muhammad Yunus. Power must be distributed more equitably between rich and poor countries, using a social business model of vaccine and drug production, he says. That means that making these pandemic-ending tools, specifically the Covid-19 vaccines, patent-free — to allow global production so they might gain traction. “There is still time for world leaders to say never again; to ensure the right to health is extended to everyone; and to commit to a fairer system of global health that prioritizes human life over the profits of a handful of pharmaceutical companies,” he says. Read more. | SEC sues executive over $5,000 in illicit profit The SEC is suing a former AstraZeneca executive on insider trading charges. It claims that Hugues Pierre Joublin, who headed corporate affairs in oncology, negotiated confidentially with Daiichi Sankyo in advance of finalizing a partnership for the cancer drug Enhertu. Using nonpublic information, the lawsuit alleges, “and in breach of his duties to AZN and its shareholders,” Joublin bought 500 shares of Daiichi for about $20,000. When the deal went public, Daiichi’s stock rose 24% — allowing Joublin “illicit profits of approximately $4,995.” | More reads - ViiV will make it easier for generic companies to copy its HIV prevention shot, but it’s not clear when. STAT
- Biden administration won’t lower seniors’ Medicare premiums this year, despite changes to coverage of new Alzheimer’s drug. STAT
- Novel cancer vaccines by Dana-Farber and Stanford look beyond T-cells to better fight tumors. FierceBiotech
| Thanks for reading! Until tomorrow,  | | | |
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